NCT07188597 Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis
| NCT ID | NCT07188597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pakistan Institute of Living and Learning |
| Condition | Individuals at Risk of First Episode Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Young people constitute nearly half of Pakistan's population and are highly vulnerable to risk factors for mental illness, including poverty, inequality, abuse, and violence. Estimates suggest that 19-34% of children and adolescents experience emotional or behavioural disorders, though this is likely underestimated. In recent years, research has focused on those at imminent risk of developing serious conditions such as first episode psychosis. The concept of an At-Risk Mental State (ARMS) has highlighted the urgent need for interventions that address current symptoms, improve functioning, and reduce transition to psychosis. Up to 80% of young people with ARMS have another diagnosable condition, and almost half show poor psychosocial outcomes even six years after initial help-seeking. Evidence demonstrates that early identification and treatment can delay or prevent psychosis, including severe and enduring illnesses like schizophrenia. Cognitive Behaviour Therapy (CBT) is among the most effective evidence-based approaches for this group. However, existing evidence comes largely from high-income countries, raising concerns about cultural applicability in low-resource settings. This study will culturally adapt and field test a manualised CBT intervention for young people at risk of first episode psychosis. To our knowledge, this is the first such study in a low-income country. Findings will inform scalable, culturally relevant interventions for Pakistan and similar contexts.
Eligibility Criteria
Inclusion Criteria: * Male or female help-seeking individual aged 16-35 years; * Score 6 or above on PQ-16 * Meet the at risk of FEP criteria using CAARMS Operationalized Intake Criteria based on three groups (vulnerability, attenuated psychosis or brief limited intermittent psychotic symptoms group); * Assessed as competent to provide informed consent. * Give written informed consent. Exclusion Criteria: * Temporary resident unlikely to be available for follow up. * Unable to engage, participate or respond to research questionnaires. * a history of psychotic illness (treated or untreated). * previous treatment with an antipsychotic or mood-stabilising agent. * active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
Contact & Investigator
Ameer B Khoso, PhD
PRINCIPAL INVESTIGATOR
Pakistan Institute of Living and Learning
Frequently Asked Questions
Who can join the NCT07188597 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Individuals at Risk of First Episode Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07188597 currently recruiting?
Yes, NCT07188597 is actively recruiting participants. Contact the research team at ameer.bukhsh@pill.org.pk for enrollment information.
Where is the NCT07188597 trial being conducted?
This trial is being conducted at Karachi, Pakistan, Karachi, Pakistan.
Who is sponsoring the NCT07188597 clinical trial?
NCT07188597 is sponsored by Pakistan Institute of Living and Learning. The principal investigator is Ameer B Khoso, PhD at Pakistan Institute of Living and Learning. The trial plans to enroll 90 participants.
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